Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system.
Am Heart J
; 275: 21-34, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38815781
ABSTRACT
Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Valva Tricúspide
/
Insuficiência da Valva Tricúspide
/
United States Food and Drug Administration
/
Cateterismo Cardíaco
/
Aprovação de Equipamentos
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Am Heart J
Ano de publicação:
2024
Tipo de documento:
Article